Job Description

The Clinical Research Coordinator (CRC) is responsible for the day-to-day coordination of clinical trials at the site level, ensuring compliance with study protocols, Good Clinical Practice (GCP) guidelines, and regulatory requirements. The CRC acts as the primary liaison between the PI, study subjects, sponsors, and the Institutional Review Board (IRB), with a primary focus on patient safety, data integrity, and protocol adherence.

• Study Initiation & Planning: Assist with site feasibility assessments, attend investigator meetings, and prepare the Investigator Site File (ISF).
• Subject Recruitment & Screening: Identify, screen, and recruit study participants based on inclusion/exclusion criteria.
• Informed Consent Process: Obtain informed consent from subjects under the guidance of the PI, ensuring they understand the study procedures, risks, and benefits.
• Study Visits & Procedures: Schedule and conduct study visits, perform study-specific procedures (e.g., vital signs, ECGs, blood draws) as per protocol.
• Data Collection & Management: Accurately collect and enter patient data into Electronic Data Capture (EDC) systems, ensuring source document accuracy and resolution of queries in a timely manner.
• Regulatory Compliance: Maintain regulatory binders, submit documents to the IRB (initials, amendments, renewals), and report Adverse Events (AEs) and Serious Adverse Events (SAEs).
• Investigational Product (IP) Management: Oversee the receipt, storage, dispensing, and accountability of investigational products.
• Lab Management: Process, store, and ship laboratory specimens according to protocol requirements.
• Liaison Duties: Act as the main contact for sponsors, Clinical Research Associates (CRAs), and vendors during monitoring visits and audits.

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